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Single Post View
Old 24th May 2017, 02:53 AM
Ashu Antil

Total Posts: 1
Re: Orthopaedic (Orthopedic) Implants - SS 316L or ISO 5832

Materials defined according to Harmonized standards to get CE marking for orthopedic implants are:
ISO 5832-1:2007
Implants for Surgery Metallic materials Part 1: Wrought stainless steel
ISO 5832-1:2007/Corr1:2008
ISO 5832-2:1999
Implants for surgery Metallic materials Part 2: Unalloyed titanium
Health Canada List of Recognized Standards for Medical Devices
Revised Date: 2016/09/19; Effective Date: 2016/10/25 17
ISO 5832-3:1996
Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium
ISO 5832-4:1996
Implants for surgery Metallic materials Part 4: Cobalt-chromium-molybdenum casting
ISO 5832-5:2005
Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel
ISO 5832-6:1997
Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromiummolybdenum
ISO 5832-9:2007
Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel
ISO 5832-11:1994
Implants for surgery Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium
ISO 5832-12:2007
Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum
ISO 5832-12:2007/Cor.1:2008

These standard contains material configuration and properties.
One can have CE certification only if material complies to these grades, but lot of companies still manufacturing implants with 316 L and having CE certification too.

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